Microcrystalline Cellulose
(Pharma Grade)

Chemicals Characteristics

Synonyms: Avicel, Solka-Floc, Cellulose Microcrystalline, α-Cellulose, Cepo, Cellulose Powder, Microcrystalline; Microcrystalline Cellulose 101
Chemical Formula: (C₁₂H₂₀O₁₀)ₙ
CAS Number: 9004-34-6

Key Points/Overview

Microcrystalline Cellulose is highly valued for its exceptional binding and compressibility properties, which significantly enhance pharmaceutical tablet formulations by improving mechanical strength, durability, and consistency. Its unique crystalline structure and particle size distribution facilitate uniform compression, ensuring reliable tablet formation and optimal drug delivery.

Additionally, its excellent flowability and compatibility with various active pharmaceutical ingredients (APIs) make Microcrystalline Cellulose indispensable in producing high-quality medicinal products across diverse industrial applications.

• Excellent Binding Capabilities: Enhances tablet strength, ensuring robust and durable formulations.

• Plastic Deformation: Undergoes efficient interparticle bonding upon compression, contributing to tablet integrity.

• Versatility: Suitable for multiple industries including pharmaceuticals, food, and cosmetics due to its stabilising and texturising properties.

Uses & Benefits

Microcrystalline Cellulose provides substantial benefits across various sectors, with detailed applications outlined below. Its multifunctional nature enables manufacturers to address formulation challenges while maintaining product consistency and regulatory compliance. Because Microcrystalline Cellulose is inert, non-reactive, and compatible with most formulation ingredients, it allows for efficient integration into existing production lines without compromising product stability or safety.

Pharmaceutical Industry

Microcrystalline Cellulose is primarily used as an essential excipient in pharmaceutical products:

• Binder and Diluent:

  • Enhances mechanical strength and stability of tablets.

  • Adjusts physical dimensions and consistency of dosage forms.

Food Industry

Microcrystalline Cellulose significantly improves texture and stability in food products:

• Texturizer:

  • Provides a consistent, smooth mouthfeel in food formulations.

Cosmetics and Personal Care

Used to enhance product consistency and efficacy in cosmetics:

• Thickening Agent:

  • Stabilises creams, lotions, and various personal care formulations.

Pharmaceutical Manufacturing

Microcrystalline Cellulose is integral to pharmaceutical processes, ensuring high-quality medicinal products:

• Tablet Compression:

  • Facilitates efficient tableting processes, improving product reliability and patient compliance.

• Controlled Drug Release:

  • Ensures consistent and controlled drug release profiles, enhancing therapeutic efficacy.

Food Production

Microcrystalline Cellulose enhances the quality and consistency of processed foods:

• Stability and Texture:

  • Improves stability and uniformity, essential for maintaining high standards in food products.

Cosmetics and Personal Care

Microcrystalline Cellulose provides essential stabilising properties for personal care formulations:

• Enhanced Stability:

  • Ensures consistent texture and viscosity, contributing to consumer satisfaction and product shelf-life.

Safety Information

Proper handling and storage of Microcrystalline Cellulose are crucial to ensuring workplace safety and product integrity. As a finely powdered material, Microcrystalline Cellulose can easily become airborne during processing or transfer, increasing the risk of inhalation or contamination.

Therefore, handling procedures must be designed to minimise dust generation and control exposure at the source, using tools such as sealed systems, local exhaust ventilation, and regular maintenance of filtration equipment. Furthermore, establishing clear labelling, secure containment, and accessible safety documentation enhances compliance and reduces the likelihood of operational errors or safety incidents.

Potential Hazards

• Skin and Eye Irritation:

  • Exposure to Microcrystalline Cellulose may lead to irritation of the skin and eyes, particularly when handled in dusty environments. The fine particles can cause mechanical abrasion or dryness, which may be uncomfortable but is typically non-serious. Protective gloves and safety goggles are recommended to reduce direct contact and mitigate these risks.

• Respiratory Risks:

  • Inhalation of airborne Microcrystalline Cellulose particles can lead to respiratory tract irritation, especially in enclosed or poorly ventilated areas. This may manifest as coughing, sneezing, or a sore throat, particularly among individuals with pre-existing respiratory sensitivities. Using dust masks or local exhaust ventilation can significantly reduce the likelihood of inhalation exposure.

• Ingestion:

  • Microcrystalline Cellulose is generally recognised as safe for oral consumption in regulated quantities, as it is not absorbed into the bloodstream and passes through the digestive system unchanged. However, excessive ingestion may result in a laxative effect or gastrointestinal discomfort, particularly in sensitive individuals or when taken in large amounts over short periods.

Safety Precautions

• Personal Protective Equipment (PPE):

  • Operators handling Microcrystalline Cellulose should wear protective gloves to prevent skin contact and irritation caused by prolonged exposure to fine particles. Safety goggles or face shields are essential to shield the eyes from airborne dust, while well-fitted particulate masks or respirators help protect the respiratory tract from inhalation risks in dusty environments.

• Ventilation:

  • It is crucial to maintain adequate ventilation, especially in production areas where Microcrystalline Cellulose is dispensed or processed. Local exhaust ventilation systems and dust collection units should be installed to capture airborne particles at the source, thereby maintaining indoor air quality and protecting worker health.

• Emergency Measures:

  • In case of accidental exposure, eyes or skin that come into contact with Microcrystalline Cellulose should be thoroughly rinsed with clean water for at least 15 minutes. Medical attention should be sought if irritation persists. Establishing clearly marked eyewash stations and safety showers in work areas can facilitate a quick response to such incidents.

Storage Recommendations

Proper storage practices to maintain Microcrystalline Cellulose’s quality and safety include:

• Container Requirements:

  • Store in dry, tightly sealed containers made from non-reactive materials such as high-density polyethylene or stainless steel. This helps prevent contamination and protects Microcrystalline Cellulose from absorbing atmospheric moisture, which can compromise its functional properties such as flowability and binding capacity.

• Optimal Conditions:

  • Maintain storage in cool, dry, and well-ventilated areas, ideally between 15°C to 25°C. Exposure to direct sunlight, humidity, or extreme temperature fluctuations should be avoided, as these conditions can degrade the physical integrity and performance characteristics of Microcrystalline Cellulose over time.

Occupational Exposure Controls

Regular implementation of exposure control strategies ensures safe Microcrystalline Cellulose handling:

• Engineering Controls:

  • Implement closed handling systems such as sealed transfer lines and enclosed mixers to minimise the release of Microcrystalline Cellulose dust into the work environment. Routine maintenance of dust extraction and filtration systems is essential to ensure effective performance and to prevent accumulation of combustible dust, which could pose a fire or explosion hazard.

• Administrative Controls:

  • Provide comprehensive training programmes for all personnel involved in Microcrystalline Cellulose handling. Training should include information on the material’s potential hazards, proper handling techniques, emergency procedures, and the correct use of personal protective equipment (PPE). Regular refresher courses help maintain awareness and compliance with safety protocols.

• Health Surveillance:

  • Conduct routine medical surveillance programmes focusing on respiratory and dermatological health for employees with frequent Microcrystalline Cellulose exposure. Early identification of symptoms related to chronic exposure, such as respiratory irritation or dermatitis, allows for timely intervention and adjustments to workplace practices or protective measures.

Environmental Impact and Disposal

Proper environmental management practices reduce Microcrystalline Cellulose-related risks by promoting sustainable usage and preventing accidental contamination. As Microcrystalline Cellulose is a biodegradable substance, it generally poses minimal threat to ecosystems. However, large-scale disposal or accidental releases into water systems should be avoided to maintain environmental integrity. Industries must adopt responsible sourcing, minimise unnecessary waste, and integrate eco-friendly processing techniques to ensure long-term environmental stewardship.

• Environmental Considerations:

  • Microcrystalline Cellulose is considered environmentally benign due to its biodegradable nature. It breaks down naturally without leaving harmful residues, posing minimal risk to terrestrial and aquatic ecosystems. Its production and disposal typically result in a low environmental footprint, making it suitable for sustainable manufacturing practices across industries.

• Disposal Guidelines:

  • Disposal of Microcrystalline Cellulose should align with regional and national environmental regulations. While it is biodegradable, waste materials should be handled responsibly to prevent unnecessary environmental load. Industries are encouraged to implement waste reduction strategies, such as reusing off-spec product or incorporating Microcrystalline Cellulose into composting systems where regulations permit.

Microcrystalline Cellulose’s exceptional versatility and safety profile underpin its extensive use across pharmaceutical, food, and cosmetic industries. Adhering to safety protocols ensures maximum benefits and minimal risks, reinforcing Microcrystalline Cellulose’s integral role in various industrial applications.